2 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Enforcement
Class II
·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.
FDA Enforcement
Class II
·Ongoing·Stryker Leibinger GmbH & Co. KG·May 29, 2024